FDA-CMS Parallel Review Process: Reflection on the Pilot Program and Adapting to Expected Guidance

Sandra Statz, MS, is VP of Clinical and Regulatory Affairs at Exact Sciences. Her key responsibilities include developing and executing comprehensive regulatory and clinical strategies, and maintaining regulatory compliance for all commercialized products. Sandra has extensive experience in clinical protocol development and clinical trial management, has supported the development of several IVD products, and led the first industry team through the pilot parallel review process resulting in simultaneous FDA approval and an NCD from CMS. Sandra also has significant experience in phase 1-3 clinical trials for oncology therapeutics and biologicals.  Prior to joining Exact Sciences, she worked for Quintiles and Third Wave Technologies (now part of Hologic).

Rochelle Fink, MD, JD
FDA-CMS Liaison
FDA

Rochelle Chodock Fink, MD, JD works on joint CMS-FDA efforts to accelerate the regulatory and coverage decision making process. This responsibility includes spending a portion of each week working in CMS’s Coverage and Analysis Group (CAG) and the remainder of the week working at FDA’s Center for Devices and Radiological Health (CDRH). Dr. Fink is involved in the FDA-CMS Parallel Review Pilot Program and CDRH’s Pre-Submission Program. As a registered patent attorney, Dr. Fink works on CDRH’s technology transfer and patent matters. Additionally, she establishes collaborations with CDRH and has been involved in the FDA-Medical Device Innovation Consortium (MDIC) effort.